The Company

Intellijoint Surgical develops effective and easy-to-use technology to enhance surgeons’ care and patients’ lives. Our technology has been used in over 70,000 hip and knee surgeries to date. IJX is a new brand within Intellijoint seeking to further commercialize our core technology on a value-added OEM basis. We are seeking a Lead Quality Analyst to accelerate the growth and sophistication of our IJX business through effective quality management.

The Position

Reporting to the Head of IJX, the Lead Quality Analyst will holistically support and mature IJX’s quality management. The Lead Quality Analyst will be responsible for quality planning in collaboration with IJX leadership, and within the context of the overall Intellijoint Surgical quality infrastructure. The successful candidate will act as the lead quality resource for the IJX product line.

The position is suited for someone who:

• Is a systems thinker that balances the rigour and control of quality management with a get-it-done attitude.
• Thrives in a project-based environment, contributing to new product development
• Is a subject-matter-expert in quality management (particularly ISO 13485)
• ​​​​​​​Strongly reflects Intellijoint values: Fast, Accountable, Ambitious, Customer Centric, and Human.

Main Duties:

• Contribute to the development of new medical device technologies on large multi-year projects, as well as smaller sustaining projects, through a quality lens.
• Own the maintenance, approval, and creation of quality documentation for IJX.
• Plan and execute production and design control deliverables, ensuring compliance with existing and new SOPs.
• Conduct gap analysis and quality planning for IJX growth and project deliverables.
• Analyze sources of quality data to identify trends and opportunities for improvement; perform ad hoc technical analyses as required.
• Perform quality assurance activities related to audits, training, change control, document, and record management.
• Represent IJX and its products during internal and external audits
• Liaise with IJX Customers’ quality and regulatory counterparts
• Collaborate cross-functionally with R&D, Operations, and other internal stakeholders as an IJX Quality champion
• Provide Operations support (e.g., approval of product records, inspections per material specifications) for the timely release and shipment of IJX products

Skills and Experience to Enable Success:

• 5+ years of relevant work experience in a regulated industry required
• Working knowledge of Medical Device standards (ISO 13485, ISO 9001, MDSAP, ISO 14971, IEC 60601)
• Experience working with software and hardware products (New Product Introduction experience is a highly desirable asset)
• Experience working cross-functionally with R&D, Production, Operations, etc., as a Quality champion
• Strong technical writing skills and adept at analyzing data
• Experience with both internal and external quality audits (experience leading audits is an asset)
• Systems thinker, comfortable with ambiguity, and is solutions-oriented
• Attention to detail and appreciation for process
• Thrives in a project-based environment

Why Join Us?

• This is a unique opportunity to build something new and impactful
• Strong support for career development and growth
• Work with innovative products that can improve surgical outcomes and enhance patients’ quality of life
• Be ready to innovate!
• Work alongside a highly talented and driven group of team members and colleagues organization-wide
• Work in an environment with high transparency and collaboration, along with lots of fun and social activities.
• Be ok with change and share in our excitement as we scale
• Flexibility so that you can do your best both at work and outside of it

Intellijoint Surgical is committed to creating an accessible and inclusive work environment. It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law.

Intellijoint Surgical encourages applications from all qualified candidates. Those in need of accommodation at any stage in the recruitment process should notify [email protected]. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.